Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
NCT ID:
NCT01392469
Description:
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement
Frequency Threshold:
2
Time Frame:
From time of first administration of study drug until end of study (up to approximately 18 months)
Study:
NCT01392469
Study Brief:
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Imatinib (400 mg/Day) + Bosentan+ Sildenafil | Following treatment period 2, the participants received concomitant treatment of oral imatinib 400 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 3. | 0 | None | 1 | 18 | 16 | 18 | View |
| Bosentan + Sildenafil | Participants received treatment with bosentan 125 mg twice daily and sildenafil thrice daily for 8 days in treatment period 1 | 0 | None | 0 | 21 | 10 | 21 | View |
| Imatinib (200 mg/Day) + Bosentan + Sildenafil | Following treatment period 1, the participants received concomitant treatment of oral imatinib 200 mg tablet daily, bosentan 125 mg twice daily and sildenafil thrice daily for 14 days in treatment period 2. | 0 | None | 2 | 19 | 9 | 19 | View |
| Total Participants | None | 0 | None | 2 | 21 | 19 | 21 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (unspecified) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (unspecified) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (unspecified) | View |
| Atrioventricular block first degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (unspecified) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (unspecified) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (unspecified) | View |
| Eyelid oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (unspecified) | View |
| Periorbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (unspecified) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (unspecified) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Haemorrhoidal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (unspecified) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (unspecified) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (unspecified) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (unspecified) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (unspecified) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (unspecified) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (unspecified) | View |
| Accidental overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (unspecified) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (unspecified) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (unspecified) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (unspecified) | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (unspecified) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (unspecified) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (unspecified) | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (unspecified) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Head discomfort | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (unspecified) | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (unspecified) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (unspecified) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (unspecified) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | View |
| Telangiectasia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (unspecified) | View |